Observational Study of Disease Severity in Participants Diagnosed With Crohn's Disease and Long Term Impact of Treatment Strategies in Participants With Moderate to Severe Crohn's Disease (Protocol P06484)

Completed

• Conditions: Crohn Disease
• Interventions: Drug: Physician standard-of-care

• Registration Number: NCT01218360
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This is an observational study to determine the prevalence of moderate to severe Crohn's disease (CD) among patients with active CD and to evaluate existing therapeutic trends in a standard clinical practice.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Study Start: 2011-11
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-18
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants	Physician standard-of-care	All participants enrolled

Primary Outcome Measures

Name	Time	Method
Record of treatment strategy followed	Week 0 to 2 years
Percentage of Crohn's disease participants among the study population with a Crohn's Disease Activity Index (CDAI) score of 220-450 at the enrollment to the study.	Week 0
Change in the CDAI score during the observational period	Week 0 to 2 years

Secondary Outcome Measures

Name	Time	Method
Number of surgeries and hospitalizations during the observational period	Week 0 to 2 years